临床试验/NCT00738322

NCT00738322已完成1 期

A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects

AstraZeneca1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2008年7月最近更新: 2009年6月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 36
试验地点: 1
主要终点: Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 20 Years 至 40 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
•Japanese males

排除标准

•ECG findings outside normal reference ranges.
•Potassium outside normal reference ranges.

研究组 & 干预措施

1

Experimental

干预措施: AZD1305 (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight

时间窗: During the study

次要结局

Pharmacokinetic variables(During the dosing visits)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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